Predicting the Risk of Venous Thromboembolism in Critically Ill Patients

NCT05498142 | Unknown

• 1 other identifier: VTEICU
• Study Type: observational
• Target: 7,600
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Venous thrombosis (VTE), including both deep vein thrombosis (DVT) and pulmonary embolism (PE) remains a frequent complication in patients admitted to the Intensive Care Unit (ICU). Multiple prediction models for estimating the risk of VTE have been developed. However, many models have not been externally validated. The aim of this study is to perform a comprehensive external validation of pre-existing prediction models for predicting the risk of in-hospital VTE in critically ill patients. In case current risk assessment models fail, the investigators aim to additionally develop and internally validate a new risk prediction model. Methods: During the first phase of the study the investigators will perform external validation of existing prediction models. The performance, discrimination, calibration and clinical usefulness of the models will be evaluated. In the second phase of the study, in case performance of current risk assessment models is deemed insufficient for clinical application, the investigators will develop a model for predicting the risk of in-hospital VTE in critically ill patients. A multivariable prediction model will be constructed using a combination of predefined candidate predictors. This model will be internally validated and performance will be compared with performance of existing VTE risk prediction models. Dissemination: This protocol will be published online. This study will be reported according to the Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) statement and this study will be submitted to a peer-reviewed journal for publication.

Conditions

Venous Thromboembolism; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Number of patients with in-hospital VTE

  VTE will be defined as any objectively proven event occurring during initial hospital admission. No screening protocol will be used. DVT will include acute thrombosis of lower-extremity veins (iliac, femoral or popliteal), confirmed by compression ultrasonography, venography, CT, MRI, or autopsy. Pulmonary embolism will be defined as acute thrombosis within the pulmonary vasculature as shown by ventilation-perfusion scan, CT angiography, or autopsy. We will include upper extremity DVT in the model but exclude venous thrombosis in any other site (e.g., portal vein thrombosis) as these may represent a different entity.

  Initial hospital admission

Study Arms (4)

SICS I

Prospective cohort study based on the 'Simple Intensive Care Studies' (SICS) registry (NCT02912624)

SICS II

Prospective cohort study based on the 'Simple Intensive Care Studies' (SICS) registry (NCT03577405)

AFIB-ICU

An international inception cohort study.

Emmen

Patients admitted to the ICU of a community hospital in the Netherlands.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population are critically ill patients who are admitted to the ICU regardless of underlying disease. We will exclude patients who were admitted after planned surgery or other procedures. We foresee that there will be differences between the selection criteria of each cohort. We will reflect on these differences in the final manuscript

You may qualify if:

• Emergency admission

You may not qualify if:

• Age \< 18 years
• Planned admission either after surgery or for other reasons

Sponsors & Collaborators

• University Medical Center Groningen: lead

Related Publications (12)

• Wetterslev M, Moller MH, Granholm A, Haase N, Hassager C, Lange T, Hastbacka J, Wilkman E, Myatra SN, Shen J, An Y, Siegemund M, Young PJ, Aslam TN, Szczeklik W, Aneman A, Arabi YM, Cronhjort M, Keus F, Perner A. New-onset atrial fibrillation in the intensive care unit: Protocol for an international inception cohort study (AFIB-ICU). Acta Anaesthesiol Scand. 2021 Jul;65(6):846-851. doi: 10.1111/aas.13827. Epub 2021 Apr 23.

  PMID: 33864378 BACKGROUND

• Gaus H, Gulzow M, Meyer-Hofmann G. [Late lesions following thorotrast use]. Klin Wochenschr. 1966 Jan 1;44(1):32-9. doi: 10.1007/BF01747176. No abstract available. German.

  PMID: 5984857 BACKGROUND

• Spyropoulos AC. Upper vs. lower extremity deep vein thrombosis: outcome definitions of venous thromboembolism for clinical predictor rules or risk factor analyses in hospitalized patients. J Thromb Haemost. 2009 Jun;7(6):1041-2. doi: 10.1111/j.1538-7836.2009.03351.x. No abstract available.

  PMID: 19548912 BACKGROUND

• Darzi AJ, Repp AB, Spencer FA, Morsi RZ, Charide R, Etxeandia-Ikobaltzeta I, Bauer KA, Burnett AE, Cushman M, Dentali F, Kahn SR, Rezende SM, Zakai NA, Agarwal A, Karam SG, Lotfi T, Wiercioch W, Waziry R, Iorio A, Akl EA, Schunemann HJ. Risk-assessment models for VTE and bleeding in hospitalized medical patients: an overview of systematic reviews. Blood Adv. 2020 Oct 13;4(19):4929-4944. doi: 10.1182/bloodadvances.2020002482.

  PMID: 33049056 BACKGROUND

• Riley RD, Debray TPA, Collins GS, Archer L, Ensor J, van Smeden M, Snell KIE. Minimum sample size for external validation of a clinical prediction model with a binary outcome. Stat Med. 2021 Aug 30;40(19):4230-4251. doi: 10.1002/sim.9025. Epub 2021 May 24.

  PMID: 34031906 BACKGROUND

• Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available.

  PMID: 32188600 BACKGROUND

• Van Calster B, Nieboer D, Vergouwe Y, De Cock B, Pencina MJ, Steyerberg EW. A calibration hierarchy for risk models was defined: from utopia to empirical data. J Clin Epidemiol. 2016 Jun;74:167-76. doi: 10.1016/j.jclinepi.2015.12.005. Epub 2016 Jan 6.

  PMID: 26772608 BACKGROUND

• Vickers AJ, Elkin EB. Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making. 2006 Nov-Dec;26(6):565-74. doi: 10.1177/0272989X06295361.

  PMID: 17099194 BACKGROUND

• Janssen KJ, Donders AR, Harrell FE Jr, Vergouwe Y, Chen Q, Grobbee DE, Moons KG. Missing covariate data in medical research: to impute is better than to ignore. J Clin Epidemiol. 2010 Jul;63(7):721-7. doi: 10.1016/j.jclinepi.2009.12.008. Epub 2010 Mar 24.

  PMID: 20338724 BACKGROUND

• Sullivan LM, Massaro JM, D'Agostino RB Sr. Presentation of multivariate data for clinical use: The Framingham Study risk score functions. Stat Med. 2004 May 30;23(10):1631-60. doi: 10.1002/sim.1742.

  PMID: 15122742 BACKGROUND

• Viarasilpa T, Panyavachiraporn N, Marashi SM, Van Harn M, Kowalski RG, Mayer SA. Prediction of Symptomatic Venous Thromboembolism in Critically Ill Patients: The ICU-Venous Thromboembolism Score. Crit Care Med. 2020 Jun;48(6):e470-e479. doi: 10.1097/CCM.0000000000004306.

  PMID: 32187076 BACKGROUND

• Schunemann HJ, Cushman M, Burnett AE, Kahn SR, Beyer-Westendorf J, Spencer FA, Rezende SM, Zakai NA, Bauer KA, Dentali F, Lansing J, Balduzzi S, Darzi A, Morgano GP, Neumann I, Nieuwlaat R, Yepes-Nunez JJ, Zhang Y, Wiercioch W. American Society of Hematology 2018 guidelines for management of venous thromboembolism: prophylaxis for hospitalized and nonhospitalized medical patients. Blood Adv. 2018 Nov 27;2(22):3198-3225. doi: 10.1182/bloodadvances.2018022954.

  PMID: 30482763 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism; Critical Illness

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: March 1, 2015
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 15, 2022

Record last verified: 2022-08